Trial to Evaluate UltraSound in the Treatment of Tibial Fractures
NCT ID: NCT00667849
Last Updated: 2015-12-08
Study Results
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View full resultsBasic Information
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TERMINATED
NA
501 participants
INTERVENTIONAL
2008-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Exogen 4000+
Single arm, Exogen 4000+
Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
Sham
Single arm, sham (identical device with the exception of administration of ultrasound).
Sham
sham device identical to active device with the exception of administration of ultrasound
Interventions
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Exogen 4000+
Low-intensity pulsed ultrasound (LIPUS)
Sham
sham device identical to active device with the exception of administration of ultrasound
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have an open or closed tibial fracture amenable to intramedullary nail fixation
Exclusion Criteria
* Pilon fractures
* Tibial fractures that extend into the joint and require reduction
* Pathologic fractures • Bilateral tibial fractures
18 Years
ALL
No
Sponsors
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McMaster University
OTHER
Clinical Advances Through Research and Information Translation
UNKNOWN
Bioventus LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Mohit Bhandari, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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San Francisco General/Dept of Orthopedic Surgery
San Francisco, California, United States
Florida Orthopedic Institute
Tampa, Florida, United States
OrthoIndy
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
Eastern Maine Medical Center
Bangor, Maine, United States
University of Missouri
Columbia, Missouri, United States
Insall Scott Kelly Institute
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Rothman Institute
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Greenville Hospital System
Greenville, South Carolina, United States
Orthopedic Specialtiy Associates
Fort Worth, Texas, United States
West Virginia University
Morgantown, West Virginia, United States
Foothills Medical Centre
Calgary, Alberta, Canada
Vancouver Coastal Health
Vancouver, British Columbia, Canada
QE II Health Sciences Centre
Halifax, Nova Scotia, Canada
Countries
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References
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Findakli F, Busse JW, Schemitsch EH, Lonn E, Farrokhyar F, Bhandari M; and the TRUST Investigators. Smoking, Obesity, and Disability Benefits or Litigation Are Not Associated with Clinically Important Reductions in Physical Functioning After Intramedullary Nailing of Tibial Shaft Fractures: A Retrospective Cohort Study. Clin Orthop Relat Res. 2021 Apr 1;479(4):805-813. doi: 10.1097/CORR.0000000000001573.
TRUST Investigators writing group; Busse JW, Bhandari M, Einhorn TA, Schemitsch E, Heckman JD, Tornetta P 3rd, Leung KS, Heels-Ansdell D, Makosso-Kallyth S, Della Rocca GJ, Jones CB, Guyatt GH. Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial. BMJ. 2016 Oct 25;355:i5351. doi: 10.1136/bmj.i5351.
Busse JW, Bhandari M, Einhorn TA, Heckman JD, Leung KS, Schemitsch E, Tornetta P 3rd, Walter SD, Guyatt GH. Trial to re-evaluate ultrasound in the treatment of tibial fractures (TRUST): a multicenter randomized pilot study. Trials. 2014 Jun 4;15:206. doi: 10.1186/1745-6215-15-206.
Dijkman BG, Busse JW, Walter SD, Bhandari M; TRUST Investigators. The impact of clinical data on the evaluation of tibial fracture healing. Trials. 2011 Nov 3;12:237. doi: 10.1186/1745-6215-12-237.
Other Identifiers
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EX-TIB-0907
Identifier Type: -
Identifier Source: org_study_id